August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Approximately 100,000 adolescents and young adults in the
United States experience a first episode of psychosis (FEP) every year. The
early phase of psychotic illness is widely viewed as a critical opportunity
for indicated prevention, and a chance to alter the downward trajectory and
poor outcomes associated with serious mental disorders such as schizophrenia.
Multi-element FEP specialty care programs can produce a range of positive
clinical and functional outcomes. The timing of treatment is critical; short
and long-term outcomes are better when individuals begin treatment close to
the onset of psychosis. Numerous studies find a substantial delay between the
onset of psychotic symptoms and the initiation of treatment; in the U.S.
treatment is typically delayed between one and three years, suggesting that
many FEP persons are missing a critical opportunity to benefit from early
intervention. Early identification, rapid referral to specialty FEP care, and
engagement in phase-specific treatment are essential to shortening the
duration of untreated psychosis (DUP) and pre-empting functional deterioration.
The World Health Organization advocates reducing DUP to 3 months or less by
addressing “bottlenecks” in the pathway from early psychosis identification
to initiation of specialty care. Accordingly, this Funding Opportunity
Announcement (FOA) will support R34 grants that (1) identify a baseline rate
of DUP in community treatment systems that include evidence-based specialty
care programs for FEP; (2) map referral pathways to FEP care, (3) identify
gaps and bottlenecks in the referral pathway, and (4) develop and pilot test
feasible strategies for substantially reducing DUP among persons with FEP.

Key Dates

Posted Date

April 10, 2013

Open Date (Earliest Submission Date)

June 1, 2013

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

July 1, 2013 and Standard
dates thereafter, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

Approximately 100,000 adolescents and young adults in the
United States experience a first episode of psychosis (FEP) every year
(calculated from McGrath, Saha, Chant, et al., 2008). The early phase of
psychotic illness is widely viewed as a critical opportunity for indicated
prevention, and a chance to alter the downward trajectory and poor outcomes
associated with serious mental disorders such as schizophrenia. Compared to
traditional treatment approaches, programs that integrate pharmacologic,
psychological, and rehabilitation interventions for FEP are associated with a
range of positive outcomes, including remission of psychotic symptoms,
lower-rates of re-hospitalization, shorter hospital stays, improved quality of
life and social functioning, increased cognitive performance, and reductions in
substance use (Penn, Waldheter, Perkins, et al., 2005). The timing of treatment
is critical; short and long-term outcomes are better when individuals begin
treatment close to the onset of psychosis (Marshall, Lewis, Lockwood, et al.,
2005; Perkins, Gu, Boteva, et al., 2005).

International consensus statements from the World Health
Organization recommend that specialty care for FEP start within 3 months of
illness onset (Bertolote and McGorry, 2005). However, more than two dozen
studies conducted worldwide have observed a substantial delay (on average 2
years) between the appearance of psychotic symptoms and the initiation of
appropriate treatment (Marshall et al., 2005). Two influential meta-analyses
have clearly established that the duration of untreated psychosis (DUP), the
time between the onset of psychosis and initiation of appropriate treatment, is
correlated with poor outcome (Marshall et al., 2005; Perkins et al., 2005). In
the United States, DUP ranges between one and three years (e.g., Hass and
Sweeney, 1992; Ho, Andreasen, Flaum, et al., 2000), suggesting that many
persons with FEP are missing a critical opportunity to benefit from early
intervention.

Research suggests that DUP can be reduced within healthcare
systems by enhancing early detection and treatment referral mechanisms (Melle,
Larsen, Haahr, et al., 2004). Reducing DUP in the United States from current
levels of 1-3 years to the international standard of no more than 3 months
should be a major focus of applied research efforts. Research to improve FEP
case identification and referral in the United States is a logical complement
to other NIMH initiatives on improving outcomes for people with FEP, such as
the Recovery
After an Initial Schizophrenia Episode (RAISE) initiative.

Nature of the Funding Opportunity

This FOA aims to support research that will (1) investigate
early links in the FEP case identification and referral chain in the United
States, and (2) develop feasible strategies for reducing delays in early
detection, speedy referral, and rapid initiation of stage-specific treatment.
The target population is not limited to first episode schizophrenia, but
includes all persons experiencing a first episode of psychosis regardless of
presenting DSM-IV diagnosis. Applications submitted to this FOA are encouraged
to base research activities in settings that link to treatment systems with
evidence-based specialty care programs for FEP. A variety of configurations are
possible, but evidence-based treatment programs typically feature use of single
antipsychotic medications, prescribed in low doses; family psychoeducation; and
supported employment (Addington, McKenzie, Norman, et al., 2013), along with
cognitive-behavioral therapy, assertive case management, and continuity of care
across inpatient and outpatient treatment settings (Bertolote and McGorry,
2005). Coordination of these treatment elements is also an important feature of
specialty care programs for FEP.

For the initial “benchmarking” phase of the research,
applications submitted to this FOA should (1) specify a scientifically
acceptable operational definition of DUP; (2) use reliable measures to quantify
overall DUP among persons who enroll in FEP specialty care; (3) map the various
referral pathways that channel persons with FEP to specialty care programs; and
(4) identify gaps and bottlenecks in these referral pathways, including
barriers that impede the following:

time to first recognize psychotic symptoms

time to refer to mental health treatment

time to enrollment in FEP specialty care programs

time to initiate stage-specific FEP treatment

Applications submitted to this FOA are encouraged to develop
and test the feasibility of strategies for reducing contributors to DUP within
the selected care setting, based on results of the benchmarking activities. It
is expected that pilot data from feasibility tests will be used to support
applications for subsequent R01 intervention studies that will compare
alternative methods for reducing DUP in community service settings. The
strategies proposed to reduce DUP should aim to close gaps as well as remove
significant bottlenecks in the referral pathway to specialty FEP care. NIMH
encourages applications that explore approaches for producing one or more of the
following:

Applications submitted to this FOA should consider “supply
side” approaches (e.g., targeting clinical and community systems), such as the
development and testing of strategies for training primary care physicians and
nurses, school and college counselors, emergency department staff, police, and
mental health “generalists” to recognize signs of early psychosis, and the
improvement of referral networks to fast-track the “on ramp” to FEP care
initiation. This FOA is also intended to encourage “demand side” approaches
(e.g., engaging people with FEP, and their family members, friends, caregivers,
etc.) to improve help-seeking, access, and engagement in care for persons with
FEP and/or youth at high clinical risk for psychosis, through education, decision-support
systems, and other tools, such as social media.

Research to reduce DUP requires expertise on the
characteristics of service delivery systems and community settings in which DUP
reduction strategies would be embedded, as well as expertise on the needs, life
circumstances, and diversity of the population of young people with FEP and/or
at high clinical risk of psychosis. Investigators should convey knowledge of
DUP assessment strategies and factors that may contribute to treatment delays
in the U.S. health care system (see Compton & Broussard, 2011).
Multi-disciplinary research teams with complementary areas of expertise are encouraged.
NIMH encourages applications that involve collaboration with stakeholders from
multiple clinical or community practice settings, as well as consumers of
services and their family members and social contacts. In addition, NIMH
welcomes applications proposing to leverage existing practice research
infrastructures such as the Mental Health Research Network (MHRN), the Clinical
Translational Science Awards Program (CTSA) and other research and practice
networks looking to conduct studies to reduce DUP. NIMH also welcomes
coordination of DUP research with other public and private initiatives that
specifically address early identification and treatment of young people at high
risk for mental illness.

This R34 FOA, and the related R01 FOA, PAR-13-187,
support experimental and quasi-experimental studies focused on designing,
refining, and testing algorithms of practical and accurate case identification
of persons with FEP and/or at high risk of psychosis within a myriad of
possible clinical and community contexts, and strategies that promote rapid
referral to the appropriate stage-specific specialty care.

Research
Topics

Applications to this FOA should focus on substantial DUP
reduction for persons with FEP. The NIMH encourages applications in which
referral to appropriate stage-specific care is feasible. This FOA supports
studies on the research topics listed below, which are intended to be
illustrative, not exhaustive:

Testing the effectiveness of strategies to improve identification
and referral of patients with FEP within emergency service systems to
appropriate stage-specific care.

Improving case identification of FEP within non-specialty
clinical and community systems (e.g., primary care, high schools, justice
settings, college campuses, or workplace).

Improving access and engagement in care of persons in the
high-risk state for psychosis, resulting in rapid FEP identification and entry
into specialty FEP care.

Improving identification of symptoms and help-seeking behavior
among people with FEP and those at high risk of psychosis by targeting these
individuals, their family members, and/or their social networks.

Developing and testing decision-support tools for improving the
matching of symptomatic and functional deficits with available service systems
within a catchment area.

Assessing the impact of high risk of psychosis/FEP public
awareness campaigns on initiation of treatment and DUP.

Social networking approaches to identify persons at high risk of
psychosis or with FEP and link to treatment.

It is expected that applications submitted to this FOA will
identify other important, innovative and impactful research topics.
Investigators considering applying to this FOA are encouraged to contact the Scientific/Research
Contact for this FOA for additional guidance prior to submitting an
application. Investigators who have already completed significant developmental
or pilot work in this area should consider an application to PAR-13-187 (R01).

The sections on pilot testing for effectiveness and on
innovative services research found inPAR-12-279 can serve as a useful guideline for the development of such studies under this FOA.
The R34 should propose the developmental work to be performed that would
enhance the probability of success in a larger study. Designs need not be reduced
scope versions of the anticipated larger study, but should instead attempt to
develop and refine the research strategies to be utilized in the subsequent
large-scale study. NIMH recognizes that while the scope of interest for
this R34 FOA is consistent across both this and the companion R01, PAR-13-187,
FOA, there are specific research topics for which the field may not yet be
ready for a large-scale trial. The R34 provides the opportunity for “high
risk, high reward studies” that may be of high priority to the NIMH.

Thus, appropriate research activities for this R34 FOA might
include: refining and pilot testing strategies for reducing DUP among people
with FEP; working out the details of the study protocols and randomization
procedures (if appropriate); examining the feasibility of recruiting and
retaining participants into the study conditions; and/or developing supportive
materials and resources. In addition, collection of preliminary data regarding
feasibility, acceptability, safety, tolerability, and target outcomes are also
appropriate. Given the intended pilot nature of the R34 mechanism, conducting a
formal test of outcomes is not required and obtaining an estimate of an effect
size may not be possible.

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons account.
If the PD/PI is also the organizational Signing Official, they must have two
distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons
account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows NIMH staff to estimate the potential review workload
and plan the review.

By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research
Strategy: For the initial “benchmarking” phase of the research,
applications submitted to this FOA should (1) specify a scientifically
acceptable operational definition of DUP; (2) use reliable measures to quantify
overall DUP among persons who enroll in FEP specialty care; (3) map the various
referral pathways that channel persons with FEP to specialty care programs; and
(4) identify gaps and bottlenecks in these referral pathways.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application corrections
that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

The NIMH R34 clinical exploratory/developmental grant is a
mechanism for supporting the development and/or pilot testing of new or adapted
interventions, pilot testing of interventions with demonstrated efficacy in
broader scale effectiveness trials, or conducting pilot innovative services
research that requires preliminary testing or development. Because this
is a clinical exploratory/developmental grant application, it need not have
extensive background material or preliminary information as one might normally
expect in an R01 application. Accordingly, reviewers will focus their
evaluation on the conceptual framework, the level of innovation, and the
potential to significantly advance our knowledge or understanding.
Reviewers will be instructed to place less emphasis on methodological details
and certain indicators traditionally used in evaluating the scientific merit of
R01 applications, including supportive preliminary data. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or, when available, from
investigator-generated data. Preliminary data are not required for R34
applications, but may be included if available.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Does the proposed approach have the potential to substantially reduce DUP in the target population of people
with FEP?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project? Do the qualifications of the PD/PI and other senior investigators include expertise in the
identification and treatment of people with FEP and expertise in the service
delivery systems or community settings in which the selected DUP reduction strategies
would be embedded?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? Are novel strategies proposed for reducing DUP among people with FEP and/or measuring DUP in
community treatment settings in the U.S.?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Does the project include a scientifically acceptable operational definition of DUP? Are
methods described for obtaining reliable estimates of DUP in community
programs? Does the project include substantial DUP reduction for persons with
FEP as a primary outcome? If clinical, community or public health settings are
involved, are stakeholders sufficiently engaged in the research process,
including project design?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please refer
to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the
committee, then the committee will consider whether the responses to comments
from the previous scientific review group are adequate and whether substantial
changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications. Following initial peer review, recommended applications will receive a second level of
review by the National Advisory Mental Health Council. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.